A number of medical diagnostic assays are designed to allow for use at the home of a patient. This reduces the cost of the assay by minimizing a medical practitioner's time required for each diagnostic assay. This is also more convenient for a patient, especially for tests that require that the patient take a sample on a number of consecutive days. Typically, the patient will apply a patient sample to a diagnostic device, such as a test card, applying samples once or once a day for several days to the test card. After the final sample is applied, the test card is sent to a medical practitioner or lab for analysis.
One example of such an assay is the fecal occult blood test sold by Beckman Coulter (Fullerton, Calif.) under the name Hemoccult® SENSA®. This assay requires a user to apply a fecal sample to a test card. This assay may either be a single application card or a series of jointed cards to which a fecal sample is applied once a day for a period of three days. Following the application of the final sample, this test card is mailed to a medical center where the applied samples are tested and the results analyzed.
Mailing such cards raises certain safety concerns. Postal and transport agency workers should not be exposed to patient samples, which may contain contagious agents. Given the present attention to safety and security, such safety concerns have become increasingly important. To address these concerns, rules have been proposed to be added to the Federal Register 39 CFR Part 111 to revise the standards for domestic mail. The proposed mailing regulations for diagnostic shipments are outlined in Section 8 of the proposed regulations. For dry specimen samples, the samples must be completely dried, and then enclosed in a primary receptacle. The primary receptacle then is enclosed in a secondary receptacle, which may serve as the outer shipping container. The secondary container must have a leak proof barrier, which would prevent both leaks from the primary container and leaks into the primary container should this mailing come into contact with a liquid.
Presently, diagnostic tests have a mailing envelope that is sent with the test. An inner layer of the envelope is waterproof to contain the material within the envelope. The outer layer of the envelope is made of a durable, tear resistant material to ensure safe transport. Generally these materials are bonded together to form a single compartment envelope for mailing.
U.S. Pat. No. 5,150,971 discloses one mailing envelope for mailing a diagnostic specimen. This envelope includes a front panel joined to a back panel, having three sides sealed together. The flap of the envelope includes at least one tab which may be folded over and secured, such that the flap and flap tab(s) are affixed to both the front and back panel.
The most common solution for compliance with the regulations is envisioned to be the use of two separate envelopes. The user would place the test card into a first envelope that would then be sealed. This envelope would then be placed into a second envelope, which is sealed. However, it is probable that a number of patients would simply discard one of the envelopes and mail the test card in one of the two envelopes. This is more likely for those tests that require a number of days to complete.
A number of different envelopes have been devised to address various mailing needs. A number of such envelopes have multiple compartments. For example, U.S. Pat. No. 4,669,651 discloses an envelope having a number of side flaps that fold over each other to form a number of staggered pockets within an envelope compartment. A single flap covers all pockets to seal these pockets. U.S. Pat. No. 3,979,051 discloses an alternative multicompartment envelope, having a top pocket and a side pocket in which overlapping construction is used to make the envelope more tear resistant. This envelope does not have sealing flaps. U.S. Pat. No. 4,669,651 discloses an envelope having a number of compartments and a single flap that seals all of the compartments. The pockets are vertically displaced by a displaced bottom portion so that the top of each compartment may be labeled and viewed, and so that all compartments may be the same depth. U.S. Pat. No. 4,305,506 discloses an envelope having an inner return envelope nested in a foldable single sheet that forms an outer envelope. None of these envelopes meet the standards for mailing a diagnostic device as set out in the Federal Regulations.
It is an object of the invention to provide an envelope for mailing diagnostic or other samples that meets the proposed federal guidelines for mailing such samples. This envelope should minimize the risk that a user would mistakenly violate the guidelines by failing to use a primary and a secondary compartment for mailing a diagnostic sample. All references noted herein are hereby incorporated by reference.